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GMDN Global Medical Device Nomenclature

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GMDN Global Medical Device Nomenclature Mark Wasmuth Secretary General GMDN Agency * * * * * * * * * * * * * * * * * Contents Background to GMDN Development of GMDN ... – PowerPoint PPT presentation

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Title: GMDN Global Medical Device Nomenclature


1
GMDN Global Medical Device Nomenclature
  • Mark Wasmuth
  • Secretary General
  • GMDN Agency

2
Contents
  • Background to GMDN
  • Development of GMDN
  • Scope of GMDN
  • Who uses GMDN
  • GMDN Data Structure
  • Using GMDN on-line Database

3
Role of Global Nomenclature
  • Single nomenclature for the GHTF Regulatory Model
  • Provide Generic Terms with Definitions
  • For efficient exchange of information between
    Manufacturers, Regulators and Healthcare
    Providers
  • Analysis of data to support patient safety
  • Support UDI

4
Nomenclature Pre 1993
  • No Consistency in Regulation (pre 1990)
  • Europe, USA, Canada, Japan, Australia and many
    other parts of the world have little or no
    established regulations
  • Result Initiative to investigate global
    procedures
  • Conference In Brussels (Autumn 1991)
  • To explore existing MD nomenclatures
  • Result No conclusion!
  • First Formal Meeting of GHTF in Tokyo (1993)
  • To establish a consistent approach to GMP, by
    using international standards for Quality Systems
  • Identified the need for a new Global Nomenclature

5
GMDN Source Nomenclature
  • Baseline data was adopted in agreement from
    existing nomenclatures
  • ECRI - UMDNS
  • FDA - CDRH
  • ISO 9999
  • EDMA
  • MHLW - JFMDA
  • NKKN

6
GMDN Development 1993 2011
  • International Standard structure
  • Resulted in ISO 152252000
  • Updated as ISO 152252010
  • Development to date
  • Establishment of GMDN Agency (2005)
  • 18,933 Preferred Terms
  • 1,980 Collective Terms (Device Attributes)
  • 16 Categories (Scope)
  • Web-based access to GMDN Members
  • Translation (ongoing)

7
Translation of GMDN for world access
  • English (Reference)
  • Japanese
  • Russian
  • Chinese (Mandarin)
  • 20 EU Languages, including
  • French
  • German
  • Italian
  • Portuguese
  • Spanish
  • Just started - Turkish, Serbo-Croat

8
GMDN Agency Governance
  • Board of Trustees
  • GHTF
  • AHWP
  • Industry and Regulators
  • Policy Advisory Group
  • GHTF
  • AHWP
  • WHO
  • Regional representatives as required

9
GMDN Categories (Scope)
  • Active implantable devices
  • Anaesthetic and respiratory devices
  • Dental devices
  • Electro mechanical medical devices
  • Hospital hardware
  • In vitro diagnostic devices
  • Non-active implantable devices
  • Ophthalmic and optical devices
  • Reusable devices
  • Single-use devices
  • Assistive products for persons with disability
  • Diagnostic and therapeutic radiation devices
  • Complementary therapy devices
  • Biologically-derived devices
  • Healthcare facility products and adaptations
  • Laboratory equipment

10
GMDN Members by Country 2009
11
Who regulates use of GMDN today?
  • Australia
  • Japan
  • Italy
  • Greece
  • Poland
  • Turkey
  • Czech Republic
  • Croatia
  • Peru
  • Mozambique
  • Spain
  • Other countries will mandate use of GMDN during
    their own time plan

12
GHTF support for GMDN
  • Position Statement Single Global Nomenclature
    System for Medical Devices (19th November 2010)
  • The GHTF therefore endorses the GMDN coding
    system as the preferred nomenclature system for
    regulatory purposes for medical devices and will
    continue to work to ensure its effective
    governance and availability.

13
FDA support for GMDN
  • UDI Conference, Baltimore, 1 December 2010
  • FDA proposes to use GMDN as part of the minimum
    data set for their UDI Database.

14
European Commission support for GMDN
  • European databank for medical devices (EUDAMED)
  • An important tool for Eudamed is the Global
    Medical Device Nomenclature (GMDN)GMDN presents
    the best practice for Eudamed purposes
  • GMDN is referenced in COMMISSION DECISION of 19
    April 2010 on EUDAMED

15
EUCOMED Support for GMDN
  • European Medical Technology Industry Association
    (EUCOMED)
  • To ensure consistency of data, Eucomed
    recommends using the GMDN nomenclature as the
    internationally recognised nomenclature

16
GMDN Preferred Term Structure
  • Term Name
  • Code
  • Definition
  • Non-evacuated blood collection tube IVD, EDTA
  • 57900
  • A non-evacuated sterile glass or plastic tube,
    sealed with a stopper, containing the
    anticoagulant ethylene diamine tetra acetic acid
    (EDTA). It is intended to be used for the
    collection, and preservation and/or transport, of
    blood for analysis and/or other investigation.
    This is a single-use device.

17
GMDN Data Structure
  • GMDN is a poly-hierarchical system
  • Preferred Terms are flat and linked to Collective
    Terms (device attributes and high-level terms)
    which are used to create poly-hierarchies
  • Collective Terms allow searches by subject group
  • CTs allow analysis of the GMDN by product
    attribute or feature

18
GMDN Collective Term Structure
19
Using GMDN (website access)
20
Using GMDN (searching for terms)
21
Using GMDN (selecting the term)
22
Using GMDN (multi-lingual display)
23
Summary
  • Endorsed by regulators and supported by
    manufacturers
  • Being used by more Regulators, Manufacturers and
    Hospitals each month
  • Has the necessary detail and tools to meet all
    Stakeholder needs
  • Database is updated daily following Manufacturer
    requests for new terms and users are
    automatically informed of any changes

24
  • Thank you for listening
  • mark.wasmuth_at_gmdnagency.org
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